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Objectives: The main objective of the study is to investigate the short-term efficacy of Acceptance and Commitment Therapy (ACT) on the simultaneous modification of biological indicators of risk and psychological well-being in patients with coronary heart disease attending cardiac rehabilitation (CR)., Design: This was a two-arm randomised controlled trial comparing a brief, manualised, ACT-based intervention with usual care (UC)., Setting: The study was conducted in an outpatient CR unit in Italy. Data collection took place from January 2016 to July 2017., Participants: Ninety-two patients were enrolled and randomised, following an unbalanced randomisation ratio of 2:1 to the ACT group (n=59) and the control group (n=33). Eighty-five patients completed the ACT (n=54) and the UC (n=31) interventions and were analysed., Interventions: The control group received UC, a 6 weeks multidisciplinary outpatient CR programme, encompassing exercise training, educational counselling and medical examinations. The experimental group, in addition to UC, participated in the Acceptance and Commitment Therapy on HEART disease (ACTonHEART) intervention encompassing three group sessions based on ACT., Outcomes: The primary outcomes were Low Density Lipoproteins (LDL)cholesterol, resting systolic blood pressure, body mass index (BMI) and psychological well-being measured by the Psychological General Well-Being Index (PGWBI). Outcome measures were assessed at baseline and at the end of CR., Results: Based on linear mixed models, no significant group × time interaction was observed for either the primary outcomes (β, 95% CI: PGWBI =-1.13, -6.40 to -4.14; LDL cholesterol =-2.13, -11.02 to -6.76; systolic blood pressure =-0.50, -10.76 to -9.76; diastolic blood pressure =-2.73, -10.12 to -4.65; BMI =-0.16, -1.83 to -1.51, all p values >0.05) or the secondary outcomes (all p values >0.05). A significant time effect was found for the PGWBI total (beta=4.72; p=0.03)., Conclusions: Although analyses revealed null findings, the results can inform the design of future ACT-based CR interventions and can help researchers to strike a balance between the idealised implementation of an ACT intervention and the structural limitations of existing CR programmes., Trial Registration Number: NCT01909102., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Heterogeneous outcome reporting is common in clinical trials focused on cardiac rehabilitation for myocardial infarction (MI); this practice often results in the exclusion of data from clinical trials in systematic reviews. Developing a core outcome set (COS) may solve this problem., Methods and Analysis: We will first identify a preliminary list of outcomes through a systematic review. Next, we will conduct semistructured interviews with patients to explore additional potential outcomes deemed important by patients. Then, we will engage various stakeholders such as clinicians, researchers and methodologists in two Delphi survey tends to refine and prioritise the identified outcomes. Subsequently, we will gather insights directly from patients with MI by administering plain language patient surveys; patients will be involved in questionnaire development. Finally, we will hold two face-to-face consensus meetings for patients and other stakeholders to develop the final COS for cardiac rehabilitation in MI., Ethics and Dissemination: The Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine approved this study (2022DZMEC-349). The final COS will be published in a peer-reviewed journal and disseminated in conferences., Trial Registration: We registered this study in the Core Outcome Measures in Effectiveness Trials Initiative (COMET) platform., Registration Number: 1725 (http://www.comet-initiative.org/studies/details/1725)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cardiac rehabilitation (CR) delivered by rehabilitation specialists in a healthcare setting is effective in improving functional capacity and reducing readmission rates after cardiac surgery. It is also associated with a reduction in cardiac mortality and recurrent myocardial infarction. This trial assesses the feasibility of a home-based CR programme delivered using a mobile application (app)., Methods: The Rehabilitation through Exercise prescription for Cardiac patients using an Artificial intelligence web-based Programme (RECAP) randomised controlled feasibility trial is a single-centre prospective study, in which patients will be allocated on a 1:1 ratio to a home-based CR programme delivered using a mobile app with accelerometers or standard hospital-based rehabilitation classes. The home-based CR programme will employ artificial intelligence to prescribe exercise goals to the participants on a weekly basis. The trial will recruit 70 patients in total. The primary objectives are to evaluate participant recruitment and dropout rates, assess the feasibility of randomisation, determine acceptability to participants and staff, assess the rates of potential outcome measures and determine hospital resource allocation to inform the design of a larger randomised controlled trial for clinical efficacy and health economic evaluation. Secondary objectives include evaluation of health-related quality of life and 6 minute walk distance., Ethics and Dissemination: RECAP trial received a favourable outcome from the Berkshire research ethics committee in September 2022 (IRAS 315483).Trial results will be made available through publication in peer-reviewed journals and presented at relevant scientific meetings., Trial Registration Number: ISRCTN97352737., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Chronic stable angina is common and disabling. Cardiac rehabilitation is routinely offered to people following myocardial infarction or revascularisation procedures and has the potential to help people with chronic stable angina. However, there is insufficient evidence of effectiveness and cost-effectiveness for its routine use in this patient group. The objectives of this study are to compare the effectiveness and cost-effectiveness of the 'Activate Your Heart' cardiac rehabilitation programme for people with chronic stable angina compared with usual care., Methods and Analysis: ACTIVATE is a multicentre, parallel-group, two-arm, superiority, pragmatic randomised controlled trial, with recruitment from primary and secondary care centres in England and Wales and a target sample size of 518 (1:1 allocation; allocation sequence by minimisation programme with built-in random element). The study uses secure web-based allocation concealment. The two treatments will be optimal usual care (control) and optimal usual care plus the 'Activate Your Heart' web-based cardiac rehabilitation programme (intervention). Outcome assessment and statistical analysis will be performed blinded; participants will be unblinded. Outcomes will be measured at baseline and at 6 and 12 months' follow-up. Primary outcome will be the UK version of Seattle Angina Questionnaire (SAQ-UK), physical limitations domain at 12 months' follow-up. Secondary outcomes will be the remaining two domains of SAQ-UK, dyspnoea, anxiety and depression, health utility, self-efficacy, physical activity and the incremental shuttle walk test. All safety events will be recorded, and serious adverse events assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be cost-utility analysis from health service perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the cardiac rehabilitation programme., Ethics and Dissemination: North of Scotland National Health Service Research Ethics Committee approval, reference 21/NS/0115. Participants will provide written informed consent. Results will be disseminated by peer-reviewed publication., Trial Registration Number: ISRCTN10054455., Competing Interests: Competing interests: NW reports additional grants from NIHR HTA outside the submitted work and deputy chair of the NIHR HTA programme funding committee (commissioned research). DL reports additional grants from the NIHR outside the submitted work and investigator-initiated educational grants from BMS and Pfizer. DL has been a speaker for Bayer, Boehringer Ingelheim, and BMS/Pfizer and has consulted for BMS, and Boehringer Ingelheim; all outside the submitted work. GHYL has been a consultant and speaker for BMS/Pfizer, Medtronic, Boehringer Ingelheim and Daiichi-Sankyo. No fees were directly received personally. BC works part-time for Welsh Government outside of the submitted work. KJ was subcommittee chair of the NIHR Programme Grants for Applied Research until 2023. BH reports additional grants from the NIHR outside the submitted work and investigator-initiated grant from Novartis. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: Congenital heart conditions are among the most common non-communicable diseases in children and young people (CYP), affecting 13.9 million CYP globally. While survival rates are increasing, support for young people adjusting to life with a heart condition is lacking. Furthermore, one in three CYP with heart conditions also experiences anxiety, depression or adjustment disorder, for which little support is offered. While adults are offered cardiac rehabilitation (CR) to support their mental and physical health, this is not offered for CYP.One way to overcome this is to evaluate a CR programme comprising exercise with mental health support (CardioActive; CA) for CYP with heart conditions. The exercise and mental health components are informed by the metacognitive model, which has been shown to be effective in treating anxiety and depression in CYP and associated with improving psychological outcomes in adult CR., Method and Analysis: The study is a single-blind parallel randomised feasibility trial comparing a CR programme (CA) plus usual care against usual care alone with 100 CYP (50 per arm) aged 11-16 diagnosed with a heart condition. CA will include six group exercise, lifestyle and mental health modules. Usual care consists of routine outpatient management. Participants will be assessed at three time points: baseline, 3-month (post-treatment) and 6-month follow-up. Primary outcomes are feasibility and acceptability (ie, referral rates, recruitment and retention rates, attendance at the intervention, rate of return and level of completion of follow-up data). Coprimary symptom outcomes (Strength and Difficulties Questionnaire and Paediatric Quality of Life) and a range of secondary outcomes will be administered at each time point. A nested qualitative study will investigate CYP, parents and healthcare staff views of CR and its components, and staff's experience of delivering CA. Preliminary health economic data will be collected to inform future cost-effectiveness analyses. Descriptive data on study processes and clinical outcomes will be reported. Data analysis will follow intention to treat. Qualitative data will be analysed using thematic analysis and the theoretical framework of acceptability., Ethics and Dissemination: Ethical approval was granted on 14 February 2023 by the Greater Manchester East Research Ethics Committee (22/NW/0367). The results will be disseminated through peer-reviewed journals, conference presentations and local dissemination., Trial Registration Number: ISRCTN50031147; NCT05968521., Competing Interests: Competing interests: AW is the creator of Metacognitive Therapy and codirector of the MCT Institute., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Cardiac rehabilitation (CR) can reduce cardiovascular mortality and improve health-related quality of life. In the United Kingdom, patient uptake of CR remains low (52%), falling well short of the target in the 2019 National Health Service long-term plan (85%). Mobile health (mHealth) technologies, offering biometric data to patients and healthcare professionals, may bridge the gap between supervised exercise and physical activity advice, enabling patients to engage in regular long-term physically active lifestyles. This randomised controlled trial (RCT) will evaluate the feasibility of mHealth technology when incorporated into a structured home-based walking intervention, in people with recent myocardial infarction., Methods and Analysis: This is a feasibility, assessor blinded, parallel group RCT. Participants will be allocated to either CR standard care (control group) or CR standard care+mHealth supported exercise counselling (mHealth intervention group). Feasibility outcomes will include the number of patients approached, screened and eligible; the percentage of patients who decline CR (including reasons for declining), agree to CR and consent to being part of the study; the percentage of patients who enrol in standard CR and reasons for drop out; and the percentage of participants who complete clinical, physical and psychosocial outcomes to identify a suitable primary outcome for a future definitive trial., Ethics and Dissemination: The trial was approved in the UK by the Northwest-Greater Manchester East Research Ethics Committee (22/NW/0301) and is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be published in peer-reviewed journals and presented at national and international scientific meetings., Trial Registration Numbers: NCT05774587., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management.Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression.This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting., Methods and Analysis: This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18-75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT., Ethics and Dissemination: Ethics approval was granted by South West-Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications., Trial Registration Number: ISRCTN14603929., Competing Interests: Competing interests: JCLR reports consulting fees from NHSX, speakers fees from Sanofi, physician services from HeartFlow and is cofounder and share-holder of Heart & Lung Imaging LTD, all outside the submitted work. JG reports speaker fees from Sanofi outside the submitted work. CA is a founder, shareholder, and director of Caristo Diagnostics, a CT image analysis company that provides the perivascular fat attenuation index (FAI) analysis used in the study. FAI is subject to patent US10,695,023B2 and patent applications PCT/GB2017/053262, GB2018/1818049.7, GR20180100490 and GR20180100510, licensed through exclusive license to Caristo Diagnostics., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Physical inactivity is a risk factor for repeat cardiac events and all-cause mortality in coronary heart disease (CHD). Cardiac rehabilitation, a secondary prevention programme, aims to increase physical activity levels in this population from a reported low baseline. This trial will investigate the effectiveness and implementation of a very brief physical activity intervention, comparing different frequencies of physical activity measurement by cardiac rehabilitation clinicians. The Measure It! intervention (<5 min) includes a self-report and objective measure of physical activity (steps) plus very brief physical activity advice., Methods and Analysis: This type 1 hybrid effectiveness-implementation study will use a two-arm multicentre assessor-blind randomised trial design. Insufficiently active (<150 min of moderate-to-vigorous physical activity per week) cardiac rehabilitation attendees with CHD (18+ years) will be recruited from five phase II cardiac rehabilitation centres (n=190). Patients will be randomised (1:1) to five physical activity measurements or two physical activity measurements in total over 24 weeks. The primary effectiveness outcome is accelerometer daily minutes of moderate-to-vigorous intensity physical activity at 24 weeks. Secondary effectiveness outcomes include body mass index, waist circumference and quality-of-life. An understanding of multilevel contextual factors that influence implementation, and antecedent outcomes to implementation of the intervention (eg, feasibility and acceptability), will be obtained using semistructured interviews and other data sources. Linear mixed-effects models will be used to analyse effectiveness outcomes. Qualitative data will be thematically analysed inductively and deductively using framework analysis, with the framework guided by the Consolidated Framework for Implementation Research and Theoretical Domains Framework., Ethics and Dissemination: The study has ethical approval (University of Canberra (ID 11836), Calvary Bruce Public Hospital (ID 14-2022) and the Greater Western Area (ID 2022/ETH01381) Human Research Ethics Committees). Results will be disseminated in multiple formats for consumer, public and clinical audiences., Trial Registration Number: ACTRN12622001187730p., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Despite proven programmes, implementing lifestyle interventions for pre-diabetes and type 2 diabetes is challenging. Cardiac rehabilitation, provide a valuable opportunity to promote the adoption of healthy lifestyle behaviours for patients with atherosclerotic cardiovascular disease (ASCVD). However, only a limited number of studies have explored the potential for reversing the underlying causes of ASCVD in this setting., Objectives: The DIABEPIC1 study is an ongoing single-arm lifestyle clinical trial to assess the feasibility of an upgraded 6-month intensive cardiac rehabilitation programme combining an innovative diet assignment with exercise training to reverse newly onset pre-diabetes (glycated haemoglobin 5.7%-6.4%) to normal glucose concentrations in patients with coronary heart disease., Methods and Analysis: 36 patients referred from the Montreal Heart Institute for cardiac rehabilitation, aged ≥40 years with a recent diagnosis of pre-diabetes in the last 6 months, will be offered to participate in the upgraded programme. Interventions will include four sessions of nutritional counselling on ultra-processed foods intake reduction and a moderate-carbohydrate (<40%) ad libitum Mediterranean diet coupled with 36 1-hour sessions of supervised exercise training (continuous and interval aerobic training, and resistance training) and educational intervention. Phase 2 will continue the same interventions adding 8:16 hour time-restricting eating (TRE) at least 5 days per week. During this second phase, exercise training will be performed with autonomy. The primary objectives will be to evaluate the recruitment rate, the completion rates at 3 and 6 months, and the compliance of participants. The secondary objectives will be to assess the proportion of prediabetic participants in remission of pre-diabetes at the programme's end and to characterise the factors associated with remission., Ethics and Dissemination: The DIABEPIC1 feasibility study is approved by the Research Ethics Board of the Montreal Heart Institute (Project Number ICM 2022-3005). Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences., Conclusions: The DIABEPIC1 trial will examine the feasibility and effectiveness of an enhanced cardiac rehabilitation programme combining exercise training with an ultra-processed food reduction intervention, a Mediterranean diet, and TRE counselling to remit pre-diabetes to normal glucose concentrations., Trial Registration Number: NCT05459987., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Exercise-based cardiac rehabilitation programmes (ExCRP) promote recovery and secondary prevention for individuals with cardiovascular disease (CVD). Despite this, enrolment and adherence to ExCRP in rural locations is low. Telehealth programmes provide a convenient, home-based intervention, but concerns remain about compliance to exercise prescription. This paper presents the rationale and protocol design to determine if telehealth delivered ExCRP is not inferior to supervised ExCRP for improving cardiovascular function and exercise fidelity., Method and Analysis: A non-inferiority, parallel (1:1), single-blinded randomised clinical trial will be conducted. Fifty patients with CVD will be recruited from a rural phase II ExCRP. Participants will be randomly assigned to telehealth or supervised ExCRP and prescribed three weekly exercise sessions for 6 weeks. Exercise sessions will include a 10 min warm up, up to 30 min of continuous aerobic exercise at a workload equivalent to the ventilatory anaerobic threshold and a 10 min cool down. The primary outcome will be change in cardiorespiratory fitness as measured by cardiopulmonary exercise test. Secondary outcome measures will include change in blood lipid profile, heart rate variability, pulse wave velocity, actigraphy measured sleep quality and training fidelity. Non-inferiority will be confirmed if intention-to-treat and per-protocol analyses conclude the same outcome following independent samples t-test with p<0.025., Ethics and Dissemination: Research ethics committees at La Trobe University, St John of God Health Care and Bendigo Health approved the study protocol and informed consent. Findings will be published in peer-reviewed journals and disseminated among stakeholders., Trial Registration Number: ACTRN12622000872730p; pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The prevalence of heart failure (HF) is increasing. Exercise-based cardiac rehabilitation (CR) reduces mortality and further improves the prognosis of patients with HF. However, the effect of different modes of CR delivery on HF remains unclear. Thus, the purpose of this study is to find out the relative efficacy and safety of different modes of CR delivery for individuals with HF using a network meta-analysis., Methods and Analysis: We will perform a systematic review and network meta-analysis of randomised controlled trials which compare different modes of exercise-based CR delivery for patients with HF. Databases including Embase, Medline, the Cochrane Central Register of Controlled Trials and Web of Science will be searched up to May 2022. The primary outcomes will focus on the functional capacity and the health-related quality of life (hr-QOL). Functional capacity will be evaluated by peak oxygen consumption (mL/kg/min) and 6 min walking test (metres). The Minnesota Living with Heart Failure questionnaire, Short Form-36, Psychometric properties of the Kansas City cardiomyopathy questionnaire and EuroQol five dimensions questionnaire will serve as measures of hr-QOL. As secondary outcomes, we will assess hospital admissions (all-cause and cardiac) and all-cause mortality, which required a minimum follow-up of 6 months, as well as adverse events during exercise training. The risk of bias for individual studies will be evaluated according to the Cochrane Handbook. The quality of evidence will be assessed by the Grading of Recommendations, Assessment, Development and Evaluation approach., Ethics and Dissemination: This study does not require ethics approval as it is based on published trials. Results of this systematic review and network meta-analysis will be submitted to a peer-reviewed journal for future publication., Trial Registration Number: CRD42021278351., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Exercise-based cardiac rehabilitation (CR) is a beneficial tool for the secondary prevention of cardiovascular diseases with, however, low participation rates. Telerehabilitation, intergrading mobile technologies and wireless sensors may advance the cardiac patients' adherence. This study will investigate the efficacy, efficiency, safety and cost-effectiveness of a telerehabilitation programme based on objective exercise telemonitoring and evaluation of cardiorespiratory fitness., Methods and Analysis: A supervised, parallel-group, single-blind randomised controlled trial will be conducted. A total of 124 patients with coronary disease will be randomised in a 1:1 ratio into two groups: intervention telerehabilitation group (TELE-CR) (n=62) and control centre-based cardiac rehabilitation group (CB-CR) (n=62). Participants will receive a 12-week exercise-based rehabilitation programme, remotely monitored for the TELE-CR group and standard supervised for the CB-CR group. All participants will perform aerobic training at 70% of their maximal heart rate, as obtained from cardiopulmonary exercise testing (CPET) for 20 min plus 20 min for strengthening and balance training, three times per week. The primary outcomes will be the assessment of cardiorespiratory fitness, expressed as peak oxygen uptake assessed by the CPET test and the 6 min walk test. Secondary outcomes will be the physical activity, the safety of the exercise intervention (number of adverse events that may occur during the exercise), the quality of life, the training adherence, the anxiety and depression levels, the nicotine dependence and cost-effectiveness. Assessments will be held at baseline, end of intervention (12 weeks) and follow-up (36 weeks)., Ethics and Dissemination: The study protocol has been reviewed and approved by the Ethics Committee of the University of Thessaly (1108/1-12-2021) and by the Ethics Committee of the General University Hospital of Larissa (3780/31-01-2022). The results of this study will be disseminated through manuscript publications and conference presentations., Trial Registration Number: NCT05019157., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Most patients with coronary heart disease experience sleep disturbances and low cardiorespiratory fitness (CRF), but their relationship during cardiac rehabilitation (CR) is still unclear. This article details a protocol for the study of sleep trajectory in patients with coronary heart disease during CR and the relationship between sleep and CRF. A better understanding of the relationship between sleep and CRF on patient outcomes can improve sleep management strategies., Methods and Analysis: This is a longitudinal study with a recruitment target of 101 patients after percutaneous cardiac intervention from the Seventh People's Hospital of Shanghai, China. Data collection will include demographic characteristics, medical history, physical examination, blood sampling, echocardiography and the results of cardiopulmonary exercise tests. The information provided by a 6-min walk test will be used to supplement the CPET. The Pittsburgh Sleep Quality Index will be used to understand the sleep conditions of the participants in the past month. The Patient Health Questionnaire and General Anxiety Disorder Scale will be used to assess depression and anxiety, respectively. All participants will be required to wear an actigraphy on their wrists for 72 hours to monitor objective sleep conditions. This information will be collected four times within 6 months of CR, and patients will be followed up for 1 year. The growth mixture model will be used to analyse the longitudinal sleep data. The generalised estimating equation will be used to examine the associations between sleep and CRF during CR., Ethics and Dissemination: Ethical approval for this observational longitudinal study was granted by the Shanghai Seventh People's Hospital Ethics Committee on 23 April 2021 (2021-7 th -HIRB-012). Study results will be disseminated in peer-reviewed journal articles., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cardiac rehabilitation (CR) is a critical treatment for patients with coronary heart disease after percutaneous coronary intervention. Unfortunately, participation and adherence of CR are unexpectedly poor. This study aims to test whether low-intensity or medium-intensity brisk walking is more helpful in improving early attendance, adherence and physical results., Methods and Analysis: This randomised controlled study will compare the effects of low-intensity and medium-intensity brisk walking to improve adherence and cardiopulmonary endurance. Participants will be randomly allocated to low-intensity or medium-intensity groups and will be followed-up for 8 weeks. Primary and secondary outcome data will be collected at baseline and at 2, 4 and 8 weeks. Primary outcomes measure changes in oxygen consumption (VO 2 ) peak value (mL/kg/min), as well as adherence. Secondary outcomes include changes in body mass index, oxygen pulse, maximal metabolic equivalent, breathing reserve, vital capacity, ratio of forced expiratory volume in 1 s to forced vital capacity, Δoxygen consumption/Δwork rate (ΔVO 2 /ΔWR), minute ventilation/carbon dioxide production and self-efficacy., Ethics and Dissemination: Ethical approval and informed consent form have been obtained from the Ethics Committee of Hebei General Hospital (approval number: NA-2021-03). The study background and main objective, as well as potential benefits and risks, will be fully explained to the participants and their families. Findings from this study will be published on academic journals in Chinese or in English for widespread dissemination of the results TRIAL REGISTRATION NUMBER: ChiCTR2100047568., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: To enhance health and prevent secondary consequences for patients with cardiovascular disease (CVD), maintenance of an active lifestyle following participation in cardiac rehabilitation (CR) is important. However, levels of physical activity often decrease after completion of a structured CR programme. Models that support long-term behaviour change with a sustained level of physical activity are imperative. The aim of this study is to evaluate the feasibility of a mobile health intervention based on the Health Action Process Approach theoretical model of behaviour change in patients with CVD for 3 months after completion of a CR programme., Methods and Analysis: In a feasibility trial design, we will recruit 40 participants from CR programmes at Slagelse Hospital, the City of Slagelse (municipality), or Holbæk Hospital. After completing the standard structured CR programme, each participant will create an action plan for physical activity together with a physiotherapist. Following that, participants are sent 2 weekly text messages for 3 months. The first text message prompts physical activity, and the second will check if the action plan has been followed. If requested by participants, a coordinator will call and guide the physical activities behaviour. The feasibility of this maintenance intervention is evaluated based on predefined progression criteria. Physical activity is measured with accelerometers at baseline and at 3 months follow-up., Ethics and Dissemination: Study approval was waived (EMN-2021-00020) by the Research Ethics Committee of Region Zealand, Denmark. Study results will be made public and findings disseminated to patients, health professionals, decision-makers, researchers and the public., Trial Registration Number: NCT05011994., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Despite extensive evidence of its benefits and recommendation by guidelines, cardiac rehabilitation (CR) remains highly underused with only 20%-50% of eligible patients participating. We aim to implement and evaluate the Country Heart Attack Prevention (CHAP) model of care to improve CR attendance and completion for rural and remote participants., Methods and Analysis: CHAP will apply the model for large-scale knowledge translation to develop and implement a model of care to CR in rural Australia. Partnering with patients, clinicians and health service managers, we will codevelop new approaches and refine/expand existing ones to address known barriers to CR attendance. CHAP will codesign a web-based CR programme with patients expanding their choices to CR attendance. To increase referral rates, CHAP will promote endorsement of CR among clinicians and develop an electronic system that automatises referrals of in-hospital eligible patients to CR. A business model that includes reimbursement of CR delivered in primary care by Medicare will enable sustainable access to CR. To promote CR quality improvement, professional development interventions and an accreditation programme of CR services and programmes will be developed. To evaluate 12-month CR attendance/completion (primary outcome), clinical and cost-effectiveness (secondary outcomes) between patients exposed (n=1223) and not exposed (n=3669) to CHAP, we will apply a multidesign approach that encompasses a prospective cohort study, a pre-post study and a comprehensive economic evaluation., Ethics and Dissemination: This study was approved by the Southern Adelaide Clinical Human Research Ethics Committee (HREC/20/SAC/78) and by the Department for Health and Wellbeing Human Research Ethics Committee (2021/HRE00270), which approved a waiver of informed consent. Findings and dissemination to patients and clinicians will be through a public website, online educational sessions and scientific publications. Deidentified data will be available from the corresponding author on reasonable request., Trial Registration Number: ACTRN12621000222842., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Preliminary evidence from clinical observations suggests that Tai Chi exercise may offer potential benefits for patients with chronic coronary syndrom (CCS). However, the advantages for CCS patients to practice Tai Chi exercise as rehabilitation have not been rigorously tested and there is a lack of consensus on its benefits. This study aims to develop an innovative Tai Chi Cardiac Rehabilitation Program (TCCRP) for CCS patients and to assess the efficacy, safety and acceptability of the programme., Methods and Analysis: We propose to conduct a multicentre randomised controlled clinical trial comprising of 150 participants with CCS. The patients will be randomly assigned in a 1:1 ratio into two groups. The intervention group will participate in a supervised TCCRP held three times a week for 3 months. The control group will receive supervised conventional exercise rehabilitation held three times a week for 3 months. The primary and secondary outcomes will be assessed at baseline, 1 month, 3 months after intervention and after an additional 3-month follow-up period. Primary outcome measures will include a score of 36-Item Short Form Survey and Chinese Perceived Stress Scale. The secondary outcome measures will include body composition, cardiopulmonary exercise test, respiratory muscle function, locomotor skills, echocardiogram, New York Heart Association classification, heart rate recovery time and laboratory examination. Other measures also include Seattle Angina Scale, Pittsburgh Sleep Quality Index, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Berg Balance Scale. All adverse events will be recorded and analysed., Ethics and Dissemination: This study conforms to the principles of the Declaration of Helsinki and relevant ethical guidelines. Ethical approval has been obtained from the Ethics Committee of Chinese People's Libration Army General Hospital (approval number: S2019-060-02). Findings from this study will be published and presented at conferences for widespread dissemination of the results., Trial Registration Number: NCT03936504., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The benefits of cardiac rehabilitation (CR) on the reduction of cardiac and all-cause mortality are well documented. However, adherence remains suboptimal in China. It is clear that traditional CR does not meet the needs of many eligible patients and innovation is required to improve its application. Home-based CR (HBCR) is a cost-effective method that may be a valuable alternative for many individuals in China. In HBCR, it is often difficult to maintain an exercise intensity that is both effective and within safe limits, factors that are essential for patient safety. Mobile health interventions have the potential to overcome these obstacles and may be efficacious in improving adherence. The purpose of this study is to evaluate whether an Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR could improve adherence to CR and to assess the effects on exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors., Methods and Analysis: We propose a single-blinded, two-arm, randomised controlled crossover study of 70 patients with coronary heart disease (CHD). Participants will be randomly assigned in a 1:1 ratio to one of the two groups. Patients in group 1 will receive the IERMS intervention together with usual care for the first 6 weeks and usual care for the last 6 weeks, while patients assigned to group 2 will receive usual care for the first 6 weeks and will use IERMS in the last 6 weeks. The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors. All secondary outcomes will be measured at baseline, 6 weeks and 12 weeks., Ethics and Dissemination: This study has been approved by the Human Research Ethics Committee of the School of Nursing, Jilin University (HREC 2019120901). The results will be published in peer-reviewed journals and at conferences., Trial Registration Number: ChiCTR1900028182; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Percutaneous coronary intervention (PCI) aims to provide instant relief of symptoms, and improve functional capacity and prognosis in patients with coronary artery disease. Although patients may experience a quick recovery, continuity of care from hospital to home can be challenging. Within a short time span, patients must adjust their lifestyle, incorporate medications and acquire new support. Thus, CONCARD PCI will identify bottlenecks in the patient journey from a patient perspective to lay the groundwork for integrated, coherent pathways with innovative modes of healthcare delivery. The main objective of the CONCARD PCI is to investigate (1) continuity of care, (2) health literacy and self-management, (3) adherence to treatment, and (4) healthcare utilisation and costs, and to determine associations with future short and long-term health outcomes in patients after PCI., Methods and Analysis: This prospective multicentre cohort study organised in four thematic projects plans to include 3000 patients. All patients undergoing PCI at seven large PCI centres based in two Nordic countries are prospectively screened for eligibility and included in a cohort with a 1-year follow-up period including data collection of patient-reported outcomes (PRO) and a further 10-year follow-up for adverse events. In addition to PROs, data are collected from patient medical records and national compulsory registries., Ethics and Dissemination: Approval has been granted by the Norwegian Regional Committee for Ethics in Medical Research in Western Norway (REK 2015/57), and the Data Protection Agency in the Zealand region (REG-145-2017). Findings will be disseminated widely through peer-reviewed publications and to patients through patient organisations., Trial Registration Number: NCT03810612., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier., Methods and Analyses: This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial., Ethics and Dissemination: Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders., Trial Registration Number: ISRCTN80441309., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Objective: To determine the effects of yoga practice on subclinical cardiovascular measures, risk factors and neuro-endocrine pathways in patients undergoing cardiac rehabilitation (CR) following acute coronary events., Design: 3-month, two-arm (yoga +usual care vs usual care alone) parallel randomised mechanistic study., Setting: One general hospital and two primary care CR centres in London. Assessments were conducted at Imperial College London., Participants: 80 participants, aged 35-80 years (68% men, 60% South Asian) referred to CR programmes 2012-2014., Intervention: A certified yoga teacher conducted yoga classes which included exercises in stretching, breathing, healing imagery and deep relaxation. It was pre-specified that at least 18 yoga classes were attended for inclusion in analysis. Participants and partners in both groups were invited to attend weekly a 6- to 12-week local standard UK National Health Service CR programme., Main Outcome Measures: (i) Estimated left ventricular filling pressure (E/e'), (ii) distance walked, fatigue and breathlessness in a 6 min walk test, (iii) blood pressure, heart rate and estimated peak VO 2 following a 3 min step-test. Effects on the hypothalamus-pituitary-adrenal axis, autonomic function, body fat, blood lipids and glucose, stress and general health were also explored., Results: 25 participants in the yoga + usual care group and 35 participants in the usual care group completed the study. Following the 3-month intervention period, E/e' was not improved by yoga (E/e': between-group difference: yoga minus usual care:-0.40 (-1.38, 0.58). Exercise testing and secondary outcomes also showed no benefits of yoga., Conclusions: In this small UK-based randomised mechanistic study, with 60 completing participants (of whom 25 were in the yoga + usual care group), we found no discernible improvement associated with the addition of a structured 3-month yoga intervention to usual CR care in key cardiovascular and neuroendocrine measures shown to be responsive to yoga in previous mechanistic studies., Trial Registration Number: NCT01597960; Pre-results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Cardiac rehabilitation (CR) programmes are well established, and their effectiveness and cost-effectiveness are proven. In spite of this, CR remains underused, especially in lower-resource settings such as Latin America. There is an urgent need to create more accessible CR delivery models to reach all patients in need. This trial aims to evaluate if the prevention of recurrent cardiovascular events is not inferior in a hybrid CR programme compared with a standard programme., Method and Analysis: A non-inferiority, pragmatic, multicentre, parallel (1:1), prospective, randomised and open with blinded endpoint assessment clinical trial will be conducted. 308 patients with coronary artery disease will be recruited consecutively. Participants will be randomised to hybrid or standard rehabilitation programme. The hybrid CR programme includes 10 supervised exercise sessions and individualised lifestyle counselling by a physiotherapist, with a transition after 4-6 weeks to unsupervised delivery via text messages and phone calls. The standard CR consists of 18-22 supervised exercise sessions, as well as group education sessions about lifestyle. Intervention in both groups is between 8 and 12 weeks. The primary outcome is a composite of cardiovascular mortality and hospitalisations due to cardiovascular causes. Secondary outcomes are health-related quality of life, exercise capacity, muscle strength, heart-healthy behaviour, return-to-work, cardiovascular risk factor, adherence, and exercise-related adverse events. The outcomes will be measured at the end of intervention, at 6 months and at 12 months follow-up from recruitment. The primary outcome will be tracked through the end of the trial. Per-protocol and intention-to-treat analysis will be undertaken.Cox regression model will be used to compare primary outcome among study groups., Ethics and Dissemination: Ethics committees at the sponsor institution and each centre where participants will be recruited approved the study protocol and the Informed Consent. Research findings will be published in peer-reviewed journals; additionally, results will be disseminated among region stakeholders., Trial Registration Number: NCT03881150; Pre-results., Date and Version: 01 October 2019., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To examine the long-term effect of a socially differentiated cardiac rehabilitation (CR) intervention tailored to reduce social inequalities in health regarding use of healthcare services in general practice and hospital among socially vulnerable patients admitted with first-episode myocardial infarction (MI)., Design: A prospective cohort study with 10 years' follow-up., Setting: Department of cardiology at a university hospital in Denmark between 2000 and 2004., Participants: Patients <70 years admitted with first-episode MI categorised as socially vulnerable (n=208) or non-socially vulnerable (n=171) based on educational level and social network., Intervention: A socially differentiated CR intervention. The intervention consisted of standard CR and expanded CR with focus on cross-sectional collaboration., Main Outcome Measures: Participation in annual chronic care consultations in general practice, contacts to general practice, all-cause hospitalisations and cardiovascular readmissions., Results: At 2-year and 5-year follow-up, socially vulnerable patients receiving expanded CR participated significantly more in annual chronic care consultations (p=0.02 and p<0.01) but at 10-year follow-up, there were no significant differences in annual chronic care consultations (p=0.13). At 10-year follow-up, socially vulnerable patients receiving standard CR had significantly more contacts to general practice (p=0.03). At 10-year follow-up, there were no significant differences in the proportion of socially vulnerable patients receiving expanded CR in the mean number of all-cause hospitalisations and cardiovascular readmissions (p>0.05)., Conclusions: The present study found no persistent association between the socially differentiated CR intervention and use of healthcare services in general practice and hospital in patients admitted with first-episode MI during a 10-year follow-up., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Exercise-based rehabilitation is a standard feature of chronic heart failure management. The effectiveness of eccentric exercise could offer new opportunities for better tailoring rehabilitation programme to patients' limitations. The goal of the study is to contrast the impact of a mixed eccentric and concentric cycling training programme, to that of conventional concentric cycling rehabilitation in patients with chronic heart failure (peak oxygen consumption (VO 2Peak ) < 15 mL⋅kg - 1 ⋅min - 1 , ejection fraction <40%)., Methods and Analysis: It is a prospective, open, controlled and randomised study (2×25 subjects) carried out in a single centre. Subjects will perform five exercise sessions per week per the randomisation outcome, with the intervention group performing eccentric in three of the five weekly sessions while the control group will perform the five sessions of concentric exercise. Cycling intensity will be the same in both groups and fixed to the power associated with the first ventilatory threshold. Self-management education programme, callisthenics sessions and muscle strength trainings will also be carried out as for any heart failure patient normally included in the rehabilitation programme. The primary outcome will be the change in distance covered during the 6 min walk test. Secondary outcomes will include other physical mobility parameters, functional exercise capacities, quality of life and body composition as well as skeletal muscle properties including mitochondrial function parameters., Ethics and Dissemination: The study has been approved by the institutional ethics review board (17.079) and the French regulatory authority for research (2017-A00969-44). Adverse events that could occur during the protocol will be reported to the principal investigator. The results will be published in an international peer-reviewed journal., Trial Registration Number: NCT03716778., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Chronic heart failure (CHF) is defined when the heart is unable to pump sufficiently to maintain blood flow to meet the body's needs, and it is caused by various cardiopulmonary diseases. CHF is a common, lifelong and costly condition. Baduanjin exercise (BDJE), a form of traditional Chinese regimen, has been integrated into China's clinical practice in recent years and has shown promise in cardiac rehabilitation of CHF patients. However, the efficacy of BDJE on CHF patients has not been fully statistically evaluated. In this study, we aim to systematically examine the efficacy and safety of BDJE for CHF patients., Methods and Analysis: A systematic literature search for articles up to October 2018 will be conducted in the following databases: Web of Science, Pubmed, Embase, Cochrane Library, Chinese Science and Technology Periodicals Database, Chinese National Knowledge Infrastructure and Wanfang Database. We will also search other resources. Randomised controlled trials that examined treatment of CHF patients with BDJE will be selected. Results will be analysed by assessing the quality of life of patients using the Minnesota living with heart failure questionnaire, and measurement of distance walked over a span of 6 min in the 6 min walk test. RevMan 5.3 will be used for data synthesis, sensitivity analysis, meta-regression analysis, subgroup analysis and risk of bias assessment. A funnel plot will be developed to evaluate reporting bias, and Begg and Egger tests will be used to assess funnel plot symmetries. Grading of recommendations assessment, development and evaluation system will be utilised to assess the quality of evidence., Ethics and Dissemination: This systematic review will be submitted to a peer-reviewed journal., Prosperoregistration Number: CRD42018114672., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The Heart Manual (HM) is the UK's leading facilitated home-based cardiac rehabilitation (CR) programme for individuals recovering from myocardial infarction and revascularisation. This audit explored patient-reported outcomes of home-based CR in relation to current Scottish, UK and European guidelines., Setting: Patients across the UK returned their questionnaire after completing the HM programme to the HM Department (NHS Lothian)., Participants: Qualitative data from 457 questionnaires returned between 2011 and 2018 were included for thematic analysis. Seven themes were identified from the guidelines. This guided initial deductive coding and provided the basis for inductive subthemes to emerge., Results: Themes included: (1) health behaviour change and modifiable risk reduction, (2) psychosocial support, (3) education, (4) social support, (5) medical risk management, (6) vocational rehabilitation and (7) long-term strategies and maintenance. Both (1) and (2) were reported as having the greatest impact on patients' daily lives. Subthemes for (1) included: guidance, engagement, awareness, consequences, attitude, no change and motivation. Psychosocial support comprised: stress management, pacing, relaxation, increased self-efficacy, validation, mental health and self-perception. This was followed by (3) and (4). Patients less frequently referred to (5), (6) and (7). Additional themes highlighted the impact of the HM programme and that patients attributed the greatest impact to a combination of all the above themes., Conclusions: This audit highlighted the HM as comprehensive and inclusive of key elements proposed by Scottish, UK and EU guidelines. Patients reported this had a profound impact on their daily lives and proved advantageous for CR., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cardiovascular disease (CVD) mortality is higher among breast cancer survivors (BCS) who receive chemotherapy compared with those not receiving chemotherapy. Anthracycline chemotherapy is of particular concern due to anthracycline-related impairment of vascular endothelial cells and dysregulation of the extracellular matrix. One strategy proven to offset these impairments is a form of exercise known as high-intensity interval training (HIIT). HIIT improves endothelial function in non-cancer populations by decreasing oxidative stress, the main contributor to anthracycline-induced vascular dysfunction. The purpose of this pilot study is to assess the feasibility of an 8-week HIIT, as well as the HIIT effects on endothelial function and extracellular matrix remodelling, in BCS undergoing anthracycline chemotherapy., Methods and Analysis: Thirty BCS are randomised to either HIIT, an 8-week HIIT intervention occurring three times per week (seven alternating bouts of 90% of peak power output followed by 10% peak power output), or delayed group (DEL). Feasibility of HIIT is assessed by (1) the percentage of completed exercise sessions and (2) the number of minutes of exercise completed over the course of the study. Vascular function is assessed using brachial artery flow-mediated dilation and carotid intima media thickness. Extracellular matrix remodelling is assessed by the level of matrix metalloproteinases in the plasma. A repeated-measures analysis of covariance model will be performed with group (HIIT and DEL group) and time (pre/post assessment) as independent factors. We hypothesise that HIIT will be feasible in BCS undergoing anthracycline chemotherapy, and that HIIT will improve endothelial function and extracellular matrix remodelling, compared with the DEL group. Success of this study will provide evidence of feasibility and efficacy to support a larger definitive trial which will impact cancer survivorship by decreasing anthracycline-induced vascular dysfunction, thereby benefiting cardiovascular markers that are related to CVD risk., Ethics and Dissemination: This trial was approved by the University of Southern California Institutional Review Board (HS-15-00227)., Trial Registration Number: NCT02454777; Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Current guidelines recommend abstinence from supervised cardiac rehabilitation (CR) exercise training for 6 weeks post-sternotomy. This practice is not based on empirical evidence, thus imposing potentially unnecessary activity restrictions. Delayed participation in CR exercise training promotes muscle atrophy, reduces cardiovascular fitness and prolongs recovery. Limited data suggest no detrimental effect of beginning CR exercise training as early as 2 weeks post-surgery, but randomised controlled trials are yet to confirm this. The purpose of this trial is to compare CR exercise training commenced early (2 weeks post-surgery) with current usual care (6 weeks post-surgery) with a view to informing future CR guidelines for patients recovering from sternotomy., Methods and Analysis: In this assessor-blind randomised controlled trial, 140 cardiac surgery patients, recovering from sternotomy, will be assigned to 8 weeks of twice-weekly supervised CR exercise training commencing at either 2 weeks (early CR) or 6 weeks (usual care CR) post-surgery. Usual care exercise training will adhere to current UK recommendations. Participants in the early CR group will undertake a highly individualised 2-3 week programme of functional mobility, strength and cardiovascular exercise before progressing to a usual care CR programme. Outcomes will be assessed at baseline (inpatient), pre-CR (2 or 6 weeks post-surgery), post-CR (10 or 14 weeks post-surgery) and 12 months. The primary outcome will be change in 6 min walk distance. Secondary outcomes will include measures of functional fitness, quality of life and cost-effectiveness., Ethics and Dissemination: Recruitment commenced on July 2017 and will complete by December 2019. Results will be disseminated via national governing bodies, scientific meetings and peer-reviewed journals., Trial Registration Number: NCT03223558; Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: To determine the contemporary effectiveness of exercise-based cardiac rehabilitation (CR) in terms of all-cause mortality, cardiovascular mortality and hospital admissions., Data Sources: Studies included in or meeting the entry criteria for the 2016 Cochrane review of exercise-based CR in patients with coronary artery disease., Study Eligibility Criteria: Randomised controlled trials (RCTs) of exercise-based CR versus a no-exercise control whose participants were recruited after the year 2000., Study Appraisal and Synthesis Methods: Two separate reviewers independently screened the characteristics of studies. One reviewer quality appraised any new studies and assessed their risk of bias using the Cochrane Collaboration's recommended risk of bias tool. Data were reported as the risk difference (95% CI)., Results: We included 22 studies with 4834 participants (mean age 59.5 years, 78.4% male). We found no differences in outcomes between exercise-based CR and a no-exercise control at their longest follow-up period for: all-cause mortality (19 studies; n=4194; risk difference 0.00, 95% CI -0.02 to 0.01, P=0.38) or cardiovascular mortality (9 studies; n=1182; risk difference -0.01, 95% CI -0.02 to 0.01, P=0.25). We found a small reduction in hospital admissions of borderline statistical significance (11 studies; n=1768; risk difference -0.05, 95% CI -0.10 to -0.00, P=0.05)., Conclusions and Implications of Key Findings: Our analysis indicates conclusively that the current approach to exercise-based CR has no effect on all-cause mortality or cardiovascular mortality, when compared with a no-exercise control. There may be a small reduction in hospital admissions following exercise-based CR that is unlikely to be clinically important., Prospero Registration Number: CRD42017073616., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Cardiac rehabilitation (CR) reduces all-cause and cardiovascular mortality in patients with coronary heart disease (CHD). Much of this improvement has been attributed to the beneficial effects of structured exercise training. However, UK-based studies have not confirmed this. Improvements in survival and cardiovascular health are associated with concurrent improvements in cardiorespiratory fitness (CRF). It is therefore concerning that estimated CRF improvements resulting from UK-based CR are approximately one-third of those reported in international literature. Modest improvements in CRF suggest that UK CR exercise training programmes may require optimisation if long-term survival is to be improved. However, contemporary UK studies lack control data or use estimates of CRF change. Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based CR is a longitudinal, observational, controlled study designed to assess the short-term and long-term effect of CR on CRF, as well cardiovascular and cardiometabolic health., Methods and Analysis: Patients will be recruited following referral to their local CR programme and will either participate in a routine, low-to-moderate intensity, 8-week (16 sessions) exercise-based CR programme or freely abstain from supervised exercise. Initial assessment will be conducted prior to exercise training, or approximately 2 weeks after referral to CR if exercise training is declined. Reassessment will coincide with completion of exercise training or 10 weeks after initial assessment for control participants. Participants will receive a final follow-up 12 months after recruitment. The primary outcome will be peak oxygen consumption determined using maximal cardiopulmonary exercise testing. Secondary outcomes will include changes in subclinical atherosclerosis (carotid intima-media thickness and plaque characteristics), body composition (dual X-ray absorptiometry) and cardiometabolic biomarkers., Ethics and Dissemination: Ethical approval for this non-randomised controlled study has been obtained from the Humber Bridge NHS Research Ethics Committee-Yorkshire and the Humber on the 27th September 2013, (12/YH/0278). Results will be presented at national conferences and published in peer-reviewed journals., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: Cardiac rehabilitation (CR) has been shown to reduce cardiovascular risk. A research project performed at a university hospital in Denmark offered an expanded CR intervention to socially vulnerable patients. One-year follow-up showed significant improvements concerning medicine compliance, lipid profile, blood pressure and body mass index when compared with socially vulnerable patients receiving standard CR. The aim of the study was to perform a long-term follow-up on the socially differentiated CR intervention and examine the impact of the intervention on all-cause mortality, cardiovascular mortality, non-fatal recurrent events and major cardiac events (MACE) 10 years after., Design: Prospective cohort study., Setting: The cardiac ward at a university hospital in Denmark from 2000 to 2004., Participants: 379 patients aged <70 years admitted with first episode myocardial infarction (MI). The patients were defined as socially vulnerable or non-socially vulnerable according to their educational level and their social network. A complete follow-up was achieved., Intervention: A socially differentiated CR intervention. The intervention consisted of standard CR and additionally a longer phase II course, more consultations, telephone follow-up and a better handover to phase III CR in the municipal sector, in general practice and in the patient association., Main Outcome Measures: All-cause mortality, cardiovascular mortality, non-fatal recurrent events and MACE., Results: There was no significant difference in all-cause mortality (OR: 1.29, 95% CI 0.58 to 2,89), cardiovascular mortality (OR: 0.80, 95% CI 0.31 to 2.09), non-fatal recurrent events (OR:1.62, 95% CI 0.67 to 3.92) or MACE (OR: 1.31, 95% CI 0.53 to 2.42) measured at 10-year follow-up when comparing the expanded CR intervention to standard CR., Conclusions: Despite the significant results of the socially differentiated CR intervention at 1-year follow-up, no long-term effects were seen regarding the main outcome measures at 10-year follow-up. Future research should focus on why it is not possible to lower the mortality and morbidity significantly among socially vulnerable patients admitted with first episode MI., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Patients with systemic inflammatory diseases such as rheumatoid arthritis (RA) have an increased risk of cardiovascular disease (CVD) above the baseline risk attributable to traditional CVD risk factors seen in the general population. Exercise in cardiac rehabilitation (CR) is designed specifically for high-risk primary prevention and those with established CVD. Even though the European League Against Rheumatism guidelines state that exercise is safe for individuals with RA and exercise can reduce CVD risk, patients with RA rarely participate in CR. Thus, little is known about CR's impact on inflammatory and CVD risk in the RA population. The purpose of this trial is to determine the feasibility of a 12-week CR programme for patients with RA and whether it decreases CVD risk without exacerbating RA., Methods and Analysis: This is a randomised controlled trial whereby 60 participants with RA will be recruited and randomly assigned to either standard of care (SOC) treatment or SOC plus a 12-week CR programme (60 min of education plus two 60 min aerobic exercise sessions/week). Exercise will be performed at 60%-80% of heart rate reserve. Outcome measures (Framingham Risk Score, resting heart rate, blood pressure, blood lipids, markers of systemic inflammation (ie, interleukin (IL) 6 and tumour necrosis factor-α (TNF-α), Clinical Disease Assessment Index, Disease Activity Score-28, physical activity levels and peak cardiorespiratory fitness) will be assessed preintervention (week-0), postintervention (week-13) and 6 months postintervention., Ethics and Dissemination: Ethical approval was obtained from the Nova Scotia Health Authority Research Ethics Board. Results will be submitted for publication in an appropriate peer-reviewed journal., Trial Registration Number: NCT01534871; Pre-results., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Exercise-based cardiac rehabilitation (CR) independently alters the clinical course of cardiovascular diseases resulting in a significant reduction in all-cause and cardiac mortality. However, only 15%-30% of all eligible patients participate in a phase 2 ambulatory programme. The uptake rate of community-based programmes following phase 2 CR and adherence to long-term exercise is extremely poor. Newer care models, involving telerehabilitation programmes that are delivered remotely, show considerable promise for increasing adherence. In this view, the PATHway (Physical Activity Towards Health) platform was developed and now needs to be evaluated in terms of its feasibility and clinical efficacy., Methods and Analysis: In a multicentre randomised controlled pilot trial, 120 participants (m/f, age 40-80 years) completing a phase 2 ambulatory CR programme will be randomised on a 1:1 basis to PATHway or usual care. PATHway involves a comprehensive, internet-enabled, sensor-based home CR platform and provides individualised heart rate monitored exercise programmes (exerclasses and exergames) as the basis on which to provide a personalised lifestyle intervention programme. The control group will receive usual care. Study outcomes will be assessed at baseline, 3 months and 6 months after completion of phase 2 of the CR programme. The primary outcome is the change in active energy expenditure. Secondary outcomes include cardiopulmonary endurance capacity, muscle strength, body composition, cardiovascular risk factors, peripheral endothelial vascular function, patient satisfaction, health-related quality of life (HRQoL), well-being, mediators of behaviour change and safety. HRQoL and healthcare costs will be taken into account in cost-effectiveness evaluation., Ethics and Dissemination: The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the director and clinical director of the PATHway study and by the ethical committee of each participating site. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses and events., Trial Registration Number: NCT02717806. This trial is currently in the pre-results stage., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Introduction: Current international guidelines for cardiac rehabilitation (CR) advocate moderate-intensity exercise training (MISS, moderate-intensity steady state). This recommendation predates significant advances in medical therapy for coronary heart disease (CHD) and may not be the most appropriate strategy for the 'modern' patient with CHD. High-intensity interval training (HIIT) appears to be a safe and effective alternative, resulting in greater improvements in peak oxygen uptake (VO 2 peak ). To date, HIIT trials have predominantly been proof-of-concept studies in the laboratory setting and conducted outside the UK. The purpose of this multicentre randomised controlled trial is to compare the effects of HIIT and MISS training in patients with CHD attending UK CR programmes., Methods and Analysis: This pragmatic study will randomly allocate 510 patients with CHD to 8 weeks of twice weekly HIIT or MISS training at 3 centres in the UK. HIIT will consist of 10 high-intensity (85-90% peak power output (PPO)) and 10 low-intensity (20-25% PPO) intervals, each lasting 1 min. MISS training will follow usual care recommendations, adhering to currently accepted UK guidelines (ie, >20 min continuous exercise at 40-70% heart rate reserve). Outcome measures will be assessed at baseline, 8 weeks and 12 months. The primary outcome for the trial will be change in VO 2 peak as determined by maximal cardiopulmonary exercise testing. Secondary measures will assess physiological, psychosocial and economic outcomes., Ethics and Dissemination: The study protocol V.1.0, dated 1 February 2016, was approved by the NHS Health Research Authority, East Midlands-Leicester South Research Ethics Committee (16/EM/0079). Recruitment will start in August 2016 and will be completed in June 2018. Results will be published in peer-reviewed journals, presented at national and international scientific meetings and are expected to inform future national guidelines for exercise training in UK CR., Trial Registration Number: NCT02784873; pre-results., Competing Interests: Conflicts of Interest: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Introduction: Sexual problems are common with cardiovascular disease, and can negatively impact quality of life. To address sexual problems, guidelines have identified the importance of sexual counselling during cardiac rehabilitation, yet this is rarely provided. The Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention aims to improve the provision of sexual counselling in cardiac rehabilitation in Ireland., Methods and Analysis: This is a multicentre pilot study for the CHARMS intervention, a complex, multilevel intervention delivered within hospital-based cardiac rehabilitation programmes. The intervention includes (1) training in sexual counselling for staff, (2) a staff-led patient education and support intervention embedded within the cardiac rehabilitation programme, (3) a patient information booklet and (4) an awareness raising poster. The intervention will be delivered in two randomly selected cardiac rehabilitation centres. In each centre 30 patients will be recruited, and partners will also be invited to participate. Data will be collected from staff and patients/partners at T1 (study entry), T2 (3-month follow-up) and T3 (6-month follow-up). The primary outcome for patients/partners will be scores on the Sexual Self-Perception and Adjustment Questionnaire. Secondary outcomes for patients/partners will include relationship satisfaction; satisfaction with and barriers to sexual counselling in services; sexual activity, functioning and knowledge; physical and psychological well-being. Secondary outcomes for staff will include sexuality-related practice; barriers to sexual counselling; self-ratings of capability, opportunity and motivation; sexual attitudes and beliefs; knowledge of cardiovascular disease and sex. Fidelity of intervention delivery will be assessed using trainer self-reports, researcher-coded audio recordings and exit interviews. Longitudinal feasibility data will be gathered from patients/partners and staff via questionnaires and interviews., Ethics and Dissemination: This study is approved by the Research Ethics Committee (REC) of the National University of Ireland, Galway. Findings will be disseminated to cardiac rehabilitation staff, patients/partners and relevant policymakers via appropriate publications and presentations., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)